Quality Assurance Assistant Partner
PRTR
- จตุจักร, กรุงเทพฯ
- งานประจำ
- ฟูลไทม์
- Quality Management System (QMS, GIP/GDPMD) and Compliance for DIA & DC
- Supporting a team in implementing a new/updated Modular Quality Management System (MQMS) within timeline.
- Assisting in conducting training sessions for new/updated MQMS modules and Global Standard procedures through the relevant functions and recording training participation in Cornerstone.
- Monitoring training completion of mQMS-related training before going live/effective (Just in time).
- Supporting for controlling GxP/QMS documents/ templates i.e. upload documents, update, retire documents in eDMS (DiaDoc), publish in RDTH Library share drive.
- Supporting for conducting quality events, workshops etc. ie. meeting room reservation, contact with external suppliers for ordering gimmicks for promotion, etc.
- Supporting follow-up with related departments for Deviation reports (NCs) and Corrective actions of internal stakeholders and Suppliers, Distributors (external) and SCARs as per timeline until closing.
- Supporting a team in managing and filing Change Control Reports and related evidence from Process owners and support to follow up with related departments for change control implementation until closing.
- Supporting document translation / reviewing from global translation as required.
- Attending local/global QA-related meetings and getting messages for actions as required.
- Supporting the team for other GxP/QMS-related activities as required.
- Supplier Management
- Supporting to find the qualified vendors for the required related services/products and support to create new vendors in the Purchasing system.
- Reviewing identified Supplier critical risk levels from owners and Periodic evaluation risk levels based on performance and internal and external requirements.
- Document control
- Filing and archiving GxP/QMS documents/records as the company required a retention period.
- Supply Chain Quality
- Working closely with the Supply Chain team and 3rd party warehouse for reading and qualifying the data logger results in the system for incoming shipments, and informing results for releasing/holding products to relevant functions.
- Creating data loggers in a Cold stream system and sending them to 3rd party warehouse for putting data loggers into the export shipments to Indo-China.
- Collaborating with the Supply Chain team and global quality supply chain for investigation of the temperature excursion case to find the root cause and CAPA.
- Supporting a team in releasing the returned products (CN) to the appropriate location and filing the return documents.
- Supporting team for change control, audit/evaluation of new 3rd party warehouse, critical suppliers etc. according to the company's standards.
- Training Administration
- Acting as a learning expert to support the QA team for the relevant GxP/QMS training i.e. Open tickets to request training curriculums, create sessions in the LMS system and Report downloading, Monitor completion of employees etc. according to the Global Standard Process - Training's requirement.
- Indo-China (Cambodia, Laos)
- Supporting team for control quality processes of distributors at Indo-China (Cambodia, Laos) of DIA and DC i.e. training, monitoring NCs, CAPA, return and destruction process as required.
- Education: Bachelor's degree in Science or other related fields.
- At least 1-2 years of experience in Quality Assurance, Quality Control in the Biotech or Pharmaceutical industry or related fields.
- Good command of listening, written and spoken English skills or TOEIC score
- Work with multiple stakeholders internally and externally.
- Strong multitasking and interpersonal skills.
- Positive attitude and willingness to learn new things.
- Sense of urgency and confidentiality.
- Ability to work in a dynamic environment, managing multiple deadlines and priorities.
- Team-oriented, actively participating and sharing opinions.